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NCT01444417 · OUTCOME

Number of Weeks With Platelet Response

Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients · Source last updated 2017-02-09

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
weeks
Interval / dispersion
Full Range
Time frame
Week 2 to week 25

What was measured

Number of weeks with platelet counts ≥ 50 x 10\^9/L during week 2 to week 25 measurements. Participants may not have had a weekly response within 4 weeks after receiving any rescue medications.

Analysis population: Efficacy analysis set

Groups in this outcome

Placebo

Participants received weekly subcutaneous placebo for 24 weeks.

Romiplostim

Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10\^9/L.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Placebo20
Romiplostim42

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Placebo1.0Not reported022Not reported
Romiplostim12.0Not reported024Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0004
    statistical Comment
    P-value from Analysis of Variance with main effects (treatment and age group) model after testing for non-significant interaction (p-value ≥ 0.10).
    statistical Method
    ANOVA
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.0004
    statistical Comment
    P-value from Analysis of Variance with main effects (treatment and age group) model after testing for non-significant interaction (p-value ≥ 0.10).
    statistical Method
    ANOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0
        upper Limit
        22
        value
        1.0
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        24
        value
        12.0
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      42
    units
    Participants
description
Number of weeks with platelet counts ≥ 50 x 10\^9/L during week 2 to week 25 measurements. Participants may not have had a weekly response within 4 weeks after receiving any rescue medications.
dispersion Type
Full Range
groups
  1. description
    Participants received weekly subcutaneous placebo for 24 weeks.
    id
    OG000
    title
    Placebo
  2. description
    Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10\^9/L.
    id
    OG001
    title
    Romiplostim
param Type
MEDIAN
population Description
Efficacy analysis set
reporting Status
POSTED
time Frame
Week 2 to week 25
title
Number of Weeks With Platelet Response
type
SECONDARY
unit Of Measure
weeks

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice